Transcript Philips Healthcare Workshop The Research and Regulatory

The Sorcerer’s Apprentice
How Medical Imaging is Changing Health Care
Eastern Radiological Society
Southern Pines, North Carolina
April 2013
A perfect metaphor…
The Sorcerer’s Apprentice
 Changing health care and imaging innovation
 An antagonistic milieu
 Barriers to innovation
 The demands of an industry focused on cost
 Changes in the payment environment and their impact on innovation
 The needs of imaging providers
Key Premises
 The success of medical imaging (almost wholly) due to
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important continuing innovation
Imaging companies and providers have prospered
The future success of medical imaging requires similar or
greater innovation
Robust innovation pipeline
Antagonistic milieu threatens realization of the promise of
future imaging innovation
Future success requires innovation that conforms to our societal
needs for beneficial technologies that provide good value at an
affordable cost
Innovators and their customers must think strategically about
which innovations to pursue or to implement in their practices
The Golden Age of Medical Imaging
 1970-present:
 Consistent stream of new and valuable technologies:
 US
 CT
 MR
 PET
 Interventional advances
 New applications of existing technologies
 Increased computing power and connectivity technologies
The Benefits of Imaging
 Improved and more reliable patient care
Screening
Diagnosis
Staging
Treatment
Response
 Less invasiveness
Marker
 No/minimal discomfort
 No/little recuperation period
 Capacity to repeat over time
 Replacement of old and outmoded procedures
Imaging Innovation Progressing Rapidly
Major shifts in imaging innovation already underway:
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Gross anatomy/pathology to cellular and subcellular imaging
Anatomic to functional imaging
General functional imaging to imaging specific targeted receptors
Qualitative to quantitative
The linking of diagnostics to therapeutics
P4 Medicine Promoting
Imaging Innovation*
 Predictive of individual patient risks to support better
disease surveillance
 Preemptive diagnosis and treatment to improve
outcomes
 Personalized diagnosis and treatment based on history
and the genome
 Participatory care in consideration of patient
preferences
*aka precision medicine, aka personalized medicine aka
molecular medicine
Imaging and P4 Medicine - Examples
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Predict susceptibility to specific diseases
Genome-informed surveillance to earlier disease
Predict biological aggressiveness/treatability
Discern the best treatment and dose before beginning therapy
Predict toxic effects
Monitor response to treatment early and accurately
Link surveillance, diagnosis, staging, and treatment in an
efficient, convenient, patient friendly paradigm
Example P4 Innovation
 Advanced pre- and intra-operative visualization
Example P4 Innovation
 Hyperpolarized noble gas MRI lung imaging for anatomic
detail and pulmonary function
Example P4 Innovation
 64-CU ATSM PET to guide intensity modulated radiation
therapy of hypoxic tumor regions
18-FDG
64-Cu ATSM
Imaging Phenotype to Predict Genotype
 Integrated databases
 Genomics
 Proteinomics
 Immunohistochemistry
 Demographics
 Clinical data
 Imaging phenotypes to predict
key diagnostic and therapeutic
events
Smart Systems
 Detection and characterization
 CADe to CADx
 Future IT systems may operate
independently or with radiologist
oversight of selected cases
 Radiologist focuses on:
 More complex and novel imaging
 Consultation and direct patient care
Or switches the paradigm
 Value to the health system
 Consultation with physicians and patients
 Leadership and participation
The Anti-Imaging Bias
 The financial success of imaging has led
to an anti-imaging bias among other
physicians and policy-makers
 Imaging has replaced others’ procedures
 Radiologists’ incomes have risen faster
then others
 Complaints that imaging procedures are
overpaid
 More money for imaging providers
means less for everyone else
Whenever a friend succeeds,
a little something in me dies.
- Gore Vidal
Imaging is the “Tall Poppy”
 Concern that much of imaging use is
“marginal” - does not improve health
 Marginal use: cost without benefit
 Index exam
 High cost, low benefit downstream
imaging due to:
 False positive results
 Incidentalomas
 Pseudodisease
 Policies to halt the rate of rise in imaging
utilization and cost
CT & MR UNIT SALES – U.S. MARKETS
Units
2000
DRA
CT
MR
1750
1500
1250
DRGs
1000
CON
750
Clinton
500
250
0
‘73 ‘75 ‘77 ‘79 ‘81 ‘83 ‘85 ‘87 ‘89 ‘91 ‘93 ‘95 ‘97 ‘99 ‘01 ‘03 ‘05 ‘07 ‘09*
Source: NEMA 2010
*Annualized
MD-Directed Services – 2000-2005
70
Imaging
Tests
Other procedures
All physician services
Major procedure
Evaluation & management
Cumulative Percent Change
60
50
40
30
20
10
0
2000
Source: MedPAC
2001
2002
2003
2004
2005
MD-Directed
Services
–
2000-2008
70
Imaging
Tests
Other procedures
All physician services
Major procedure
Evaluation & management
Cumulative Percent Change
60
50
40
30
20
10
0
2003
Source: MedPAC
2004
2005
2006
2007
2008
It Worked Once, So…
 2010 Patient Protection &
Affordable Care Act
 Further and more severe
technical fee reductions
 Targeted in-office imaging and
non-hospital testing facilities
 Concern that there is still
another “bone” to be found in
the same whole…perhaps a
whole carcass
The sun don’t shine on
the same dog’s tail all the
time.
- Sam Snead
Industry’s Perfect Storm
 Legislation and regulation to reduce payments
 2005 Deficit Reduction Act
 2010 Patient Protection and Affordable Care Act
 Worldwide recession
 Lost jobs and health insurance
 Employers shift of financial responsibility to patients
 RBMs and pre-authorization
 Concerns over diagnostic radiation
ALL LEADING TO
 Reduced imaging utilization
 Fewer new imaging providers
 Less reinvestment by current providers
DIMINISHED SALES OF DEVICES
and
GREATER CAUTION IN PURSUING INNOVATION
Innovation in the U.S.
 Declining capital markets
 Reduced venture capitalist spending due
to recent losses
 Especially affects “more adventurous firms”
 Major implications for job growth
 Tightened immigration policies
 1995-2005: 40% of new companies
started by immigrants or their children
 Immigrants with 2X the patent rate of
people born in the U.S
 Heavy-handed university patent policies
 Diminished commercialization of grant-
funded discoveries
- Schumpeter – Fixing the Capitalist
Machine, The Economist, Sept. 29, 2012
Era of Caution in Imaging Innovation
 Static grant funding for idea generation
 Fear over new reimbursement attacks
 Uncertainty over world financial markets
 Uncertainty about how medical services might be paid for
in the future
The strategic question is:
Be a real innovator with mission to improve patients’ health
versus
A “me too” company with diminished expectations
Barriers to Successful Innovation
 Research and development
 The fish ladders
 FDA approval
 CMS and private coverage
 Demonstration to patients,
providers, and society of:
 Benefit
 Value
 Affordability
The Costs of Innovation
 Innovation development and assessment translates to time
and money
 Direct costs of development and testing
 Opportunity costs
 3-7 years typical for important new devices
 >$100M
 >10 years for new drug, contrast agent, radiopharmaceutical
 >1B
 “Dry holes”
Fish Ladders - FDA
 Considerations of “safety and efficacy”
 Underfunded - FDA actions taking longer than regulatory rules allow
 Insufficient guidance on what is required for new types of technology
 Political disarray
 Whistle blowers
 Fear of approving advanced technologies with possible hidden risks
Fish Ladders - FDA
Jae Choi; Janus Head Consulting
Source: Clinical Device Group, Inc.
Medical Devices: Minor Innovations
Number of 510k clearances vs. time
From 1996 to 2011
Jae Choi; Janus Head Consulting
Choi et al; Source: Data from FDA
Minor Innovations: Specific Types of Devices
Number of 510k clearances vs. time for Cardiovascular, CNS, and Radiology
From 1996 to 2011
Jae Choi; Janus Head Consulting
Choi et al; Source: Data from FDA
Medical Devices:
Major Innovations
Number of PMA approvals vs. time for
Cardiovascular, CNS, and Radiology
From 1980 to 2011
Jae Choi; Janus Head Consulting
Choi et al; Source: Data from FDA
Fish Ladders - CMS
 Medicare coverage essential to success
 Private payers follow Medicare
 Coverage for “medical necessity”
 Innovation provides a benefit to patients
 Evidence that the innovation is finding a
niche in practice
 Local vs. national coverage decisions
 Coverage with evidence development
 Limited coverage for sites collecting data in
deemed trials/registries
The boys all took a flier at the
Holy Grail now and then. though
none of them had any idea where
the Holy Grail really was, and I
don't think any of them actually
expected to find it, or would
have known what to do with it if
he had run across it.
- Mark Twain
Measuring Benefit
 Improved health a difficult task for imaging innovations
 Imaging a single link in the Dx/Rx chain
 The organizational structure for rigorous trials is overwhelmed
 Attributing a health benefit to a diagnostic test takes:
 Big numbers
 Big time
 Big money
Acceptance and Dissemination
 Future innovations must overcome
4 hurdles
 Benefits to patients
 Improved care and/or health
 Less discomfort/invasiveness
 Higher efficiency/convenience/painless
 Attractiveness to providers
 Efficient
 Fits into the context of their practices
 Easily learned
 Profitable
 Value: a reasonable ratio of cost/benefit in the context of existing options
 Affordability to society
Out with the Old, In with the Old
 Accountable care organizations (ACOs)
 Managed care light from your friendly managed care provider
 Deemed providers assume responsibility for a regional population
 Provide inpatient and outpatient care, as well as preventative and early detection services
 ACOs assume risk - fixed payment per beneficiary plus profit-sharing
 Competition over cost and quality
 ACOs alter incentives to restrict care
 Services like medical imaging become cost centers
 Rationed resource overseen by:
 RBMs or decision support software
 Utilization review
 Metrics to assess completeness and quality of care
 Correct aberrant incentives to provide “the right amount of care”
The Future of Fee-for-Service Payment
 Shift to bundled payments won’t happen overnight
 Continued attacks to make imaging less profitable
 Future attacks on technical fees
 The anti-imaging bias
 Persistent erroneous belief that imaging use and cost continues to rise
 Undocumented belief that imaging codes are overpaid
 Need for federal cost savings
 It worked before!
 Professional fees - Congressional and private insurance efforts to achieve
savings from “efficiencies” in interpreting contiguous exams on the same
patient performed on the same day
 Progressive empowerment of radiology benefits management (RBMs) firms
The Transition Period - A Foot in Both Camps
 Fee-for-service incentives: Volume is king
 Streamline workflows to increase capacity for new work
 ACO incentives: Value is king
 Streamline workflows to:*
 Focus on outcomes
 Redefine productivity beyond RVU production
 Become leaders on medical staffs and in the community
 Become “visible” to patients and referring physicians
 Establish the role of imaging in new delivery systems
 Inefficiencies in workflow put practices at risk
*From ACR’s Imaging 3.0
Summary
Innovators
 Think strategically about which
technologies can cross “the 4
hurdles”
 Stage research to maximize
information at the lowest cost
 Consult customers early and often
 Track secular changes that may
impact the value of future
technologies
 Be ruthless in go/no go decisions
Providers
 Track technologies during
development and testing
 Weigh the potential of
implementation for improving
efficiency
 Evaluate the relative advantages of
early versus later adoption
 Consider local payment approaches
and ACO trajectory
 Assess the impact of an innovation
on perceptions of patients,
physicians, and the health system
[email protected]
Golf appeals to the idiot in
us and the child. Just how
child-like golf players
become is proven by their
frequent inability to count
past five
- John Updike